Multiple Sclerosis for A Roadmap to Defeat - Treasury.gov.au
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IMPLEMENTATION PLAN for A Roadmap to Defeat Multiple Sclerosis in Australia
Contents
Foreword from the Hon. Greg Hunt MP 3
About the Implementation Plan 5
What is multiple sclerosis? 7
Key facts & figures 8
Time for action 10
OBJECTIVE 1 – Better treatments, prevention and,
ultimately, a cure for the disease 14
Priority 1 – Build Research Capability and Capacity 15
Priority 2 – Harness and Improve Collaboration through
Shared Infrastructure 17
Priority 3 – Clinical Trials to cure and prevent MS 20
OBJECTIVE 2 – Improved Management and care of
people living with MS 24
Next steps and early priorities 32
References 33
Acknowledgements 33
Dr Sarah Spencer
ii Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 1
Foreword from The Hon Greg Hunt MP
Multiple sclerosis (MS) is the most common chronic disease of the central nervous system
among young Australians. It affects more than 25,000 people in Australia and is 3 times
more common in women than in men.
When they should be thinking of careers, starting a family, travel or just living life to the
fullest, up to 10 Australians each week will be informed of a diagnosis which may challenge
some of those dreams.
We are galvanised and genuinely captivated by the degree of progress that we have seen
in offering much better treatments to halt MS, and improved ways to diagnose the disease
and emerging treatments for progressive MS, that have been introduced largely over the
last 10 years. However, we are also aware of the significant work that is still ahead of us to
ensure that everyone with MS has effective treatment options, not just some, and that MS
is managed most effectively to optimise quality of life.
Thanks to an army of people living with MS, our very best Australian MS researchers,
neurologists, nurses and allied health professionals and the national organisations – MS
Research Australia and MS Australia – working collaboratively with each other and the
Commonwealth Department of Health, we now have a Roadmap to Defeat MS and this
document, the National Implementation Plan for A Roadmap to Defeat MS which provides a
tactical and cohesive strategy for exactly how we will achieve that goal of ending MS. On the
The Hon. Greg Hunt presentng at the Roadmap to Defeat Multiple Sclerosis in Australia launch event following pages, you will find the blueprint to tackle MS in a multi-pronged attack. Through
more high-quality medical research, cutting edge clinical interventions, new collaborative
programs of research and better management and care of people living with MS.
The Government is committed to support research initiatives that would improve health
outcomes and quality of life of patients with devastating conditions, such as MS.
This comprehensive plan was developed over more than 9 months by a truly dedicated
team. I wish to particularly thank all of those living with MS that have been part of this plan
by sharing their own experiences with me and other parliamentarians and by participating
in multi-stakeholder events that showcase how feasible it is for us to collaborate to stop
and reverse MS. The national research organisation – MS Research Australia – may have
set both audacious and time bound goals — but they are attainable. All of the experts are
united in that assertion. Now is not the time to rest on our laurels or pat ourselves on the
back for the last 10 years of stellar progress, now is the time to finish the job.
It is my sincere hope that this National Implementation Plan for A Roadmap to Defeat MS
will serve to change the lives of people living with MS, their friends and families now and
in to the future. I look forward to all state and territory governments also playing a part in
the overall goals, objectives and actions of the plan. Now is the time to act with momentum
firmly swinging in our favour.
Left to right: Senator David Busby, Simon McKeon AO, Jillian Kingsford Smith, Deidre McKechnie, Astrid Edwards, The Hon. Greg Hunt MP
The Hon. Greg Hunt and Dr Matthew Miles. Minister for Health
2 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 3
About the Implementation Plan How the Roadmap works
What is paramount to the success of such an audacious plan is the singular, comprehensive
and cohesive oversight and implementation of all the elements of this plan.
Background
MS Research Australia and MS Australia, whilst working with their key implementation
A Roadmap to Defeat Multiple Sclerosis in Australia was developed due to a request from
partners, have the core capabilities, expertise, staffing, knowhow and relationships with MS
the Commonwealth Health Minister, the Hon. Greg Hunt MP. He officially launched the
researchers both nationally and globally, to perform that critical role. In bringing together
Roadmap in Canberra on World MS Day 2018.
the implementation plan for the Roadmap it was identified that the work needed to achieve
The launch event included a key note introduction from Mr Simon McKeon AO, Founding our first goal of better treatments, prevention and ultimately, a cure for the disease, could
Chairman and now Patron of MS Research Australia and 2011 Australian of the Year. be streamlined under three broad objectives. The original priorities of the Roadmap have
Mr McKeon led the 2013 strategic review on health and medical research in Australia known been aligned with these objectives to accelerate implementation.
as the McKeon Review.
Many elements of this plan align with the priorities of the Medical Research Future Fund
As someone living with MS himself, Mr McKeon has been a strong supporter of increased MRFF and intersect with MRFF activities and key considerations. However, a piecemeal
research funding for people living with MS. Following the launch, the Roadmap received approach will be inefficient and will not allow us to build the momentum and coordination
bipartisan government support and the Health Minister committed to work with both necessary to accelerate progress and deliver solutions to people with MS within an
MS Australia and MS Research Australia to develop an implementation plan to ensure that acceptable time frame.
the momentum on this important initiative continued at pace.
Overall objectives FUNDING REQUIRED TO IMPLEMENT THE ROADMAP
The overall objectives of the Implementation Plan for A Roadmap to Defeat Multiple Sclerosis
Total investment of $55 million
in Australia addresses the two fundamental needs of people with MS in Australia.
• $20 million for innovative pre-clinical and clinical • $3 million to improve the secondary prevention of
research studies on nerve repair and protection to MS by addressing modifiable lifestyle risk factors.
minimise the impact of all forms of MS.
• $8 million to support national clinical trials and
1 2
• $12 million investment over ten years in Australian arms of international clinical trials.
+
competitive and prestigious researcher programs
• $2.5 million to support and implement clinical
to retain, sustain and grow the pool of high quality
studies that aim to prevent MS.
researchers in Australia; individuals who have
BETTER IMPROVED excelled or show potential to excel in MS research. • $2 million to expand access to Autologous Haem-
TREATMENTS, MANAGEMENT AND atopoietic Stem Cell Transplant (AHSCT) for MS.
• $5.5 million to develop and improve infrastructure
PREVENTION AND, CARE OF aimed at optimising personalised management • $2 million investment to establish, build and audit
ULTIMATELY, PEOPLE LIVING and prevention of MS. national care pathways.
A CURE FOR THE WITH MS
Funding Source
DISEASE
$30 million
investment from the Medical Research Future Fund $20 million
and other Federal Government funding commitment from
sources over 10 years. MS Research Australia
to part match the
$5 million government funding of
from the MS research.
Commonwealth Primary Health Network funding.
4 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 5
What is multiple sclerosis (MS)?
S is the most commonly acquired neurological disease in younger adults around
M
the world with over 2.3 million people affected.
More than 25,600 Australians live with MS and over 7.6 million Australians know or have a
loved one with this potentially debilitating disease.
S is the result of damage to myelin – a protective sheath surrounding nerve fibres of the
M
central nervous system. When myelin is damaged, this interferes with messages between
the brain and other parts of the body. The symptoms of MS are different for each person;
sometimes they even vary within the same person. For some, MS is characterised by periods
of relapse and remission, while for others it has a progressive pattern. For everyone, it
makes life unpredictable.
25,600+ AUSTRALIANS
are living with MS
30-40
The average
age of diagnosis
Of every 4 Australians diagnosed with MS
Mike Hemingway, diagnosed with MS in 2003,
Kerrie Newton, diagnosed with MS in 2008 and
3 WILL BE WOMEN
Emma Giunti, diagnosed with MS in 2010
6 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 7
Key MS facts & figures
• MS causes significant disruption and can cause chronic disability to people in the prime
of their lives and therefore has a substantive health burden and economic cost to the
Australian health system.
• The prevalence of MS in Australia has increased by over 20% since 2010 – yet experts
predict that 90% of MS cases could be preventable.
• 10 people on average are diagnosed with MS every week.
• The average age of diagnosis is between 30-40 and around 75% of those affected with
MS in Australia are female.
• There is overwhelming evidence that MS is caused by an autoimmune process with
both genetic and environmental contributors.
• The direct and indirect costs to the Australian community are increasing and now
exceed $1.75 billion every year. Nearly 32% of this figure is through the lost wages for
Australians living with MS and their carers.
• 12 therapies are available for relapsing MS but treatment response varies enormously
and methods to target and personalise treatment to optimise management and prevent
disability accumulation are urgently needed.
• Only one therapy has been approved by the Australian Therapeutic Goods Administration
(TGA) for progressive forms of MS, but is yet to be PBS-listed. Solutions to stop and
reverse the progress of MS for people with progressive forms of MS are urgently needed.
• Australia has a mid to high incidence of MS compared with other countries, with
105 Australian people in every 100,000 having a diagnosis of MS. As with the global
prevalence of MS, there is a significant latitudinal gradient in MS prevalence in Australia,
where the prevalence of MS in Tasmania is double that of Queensland1.
Renee Coffey, diagnosed
with MS in 2011
Dr Steven Petratos
8 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 9
Time for action MS Research Australia has also worked closely with the National Health and Medical
Research Council (NHMRC) over the last decade, often co-funding MS research projects.
A concerted, cohesive program of work has been identified that will accelerate MS Research Australia is a category 1 funder of research, the only national MS not-for-
solutions for people with all forms of MS, across the full spectrum of MS from primary profit organisation in Australia to be able to provide prestigious grant funding of this nature.
prevention to halting and reversing disability for those most severely affected. Moreover, this funding model has allowed MS researchers to leverage funding from other
Whilst there are positive signs that the landscape is improving for people with MS in Australia competitive sources. On average, researchers receiving our category 1 funding are able
thanks to research and treatment successes, on average, the quality of life indices of the to leverage further competitive and philanthropic funds by a factor of 5 times the original
Australian MS population remains 31% less than the Australian population norm. investment. This is increased to 27:1 for our successful incubator grant applicants.
The economic costs associated with MS per annum have increased by 41% since 2010.
However, importantly, robust scientific evidence exists which suggests that up to 90% of MS Research Australia achievements
MS cases may be preventable 2.
Key recommendations from our recent report, The Health Economic Impact of MS in • The largest trial of its kind in the world studying vitamin D
Australia in 2017, noted that: and MS prevention (PrevANZ);
• Interventions to prevent people from developing MS are crucial; • The support of the Australian New Zealand MS Genetics
Consortium (ANZgene) which led to the discovery of two
• Improving early diagnosis and affordable access to effective treatments are essential; major MS risk genes and contributed to the discovery of Established the first ever
• There should be a continued focus on managing symptoms and supporting people with now over 200 gene variations through the International MS
VITAMIN D
MS and their carers in employment; Genetics Consortium;
MS Prevention Trial
• Quality of life of people with MS could be significantly improved through effective and • In addition to these two collaborations, the funding and
specific interventions; coordinating of a further 6 major research platforms to
bridge knowledge gaps;
• Interventions and support to help people with MS to maintain physical health as they
age will also improve quality of life for older people with MS. • Initiation of the first ever Australian MS Longitudinal Study )
AMSLS) tracking patient-reported outcomes in MS – a study
that has transformed advocacy and support for people with
There is significant evidence that there has been more progress in MS in Australia;
MS than in any other neurological disease in the world. However,
with the serious burden for people with MS and the community, in
• A world-first blood biomarker discovery to help differentiate
between the different types of MS; 900+
terms of both quality of life and economic impact, there is still a
great need for urgent action. • First ever joint research fellowship awarded by MS Research Australian researchers
Australia in partnership with JDRF Australia to identify the and clinicians working
on MS
Australian collaboration common genetic pathways in MS and type 1 diabetes driving
Australian MS research has a rich and successful history with autoimmunity in both diseases;
significant research strengths in many different Universities and • Funding of over 270 research grants awarded by
medical research institutes. Many of our talented MS researchers MS Research Australia;
are amongst the world’s best and global leaders in their fields of
MS research. Australia has been involved with, or led, many of the
• In excess of $44.3 million committed to MS research by
MS Research Australia;
world’s most successful MS research collaborations over the last
two decades, with the majority of national collaborations having • Funding to over 50 Universities and medical research
been funded and facilitated by MS Research Australia, whose institutes in Australia; and
track record in leading and coordinating major collaborative efforts • Helping to build the capacity for MS research in Australia
in MS research is second to none.
OVER 270
with a critical mass of over 900 clinicians and scientists research grants awarded by
focusing on MS in Australia. MS Research Australia
10 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 11
International collaboration Top three research priorities for MS
MS Research Australia, MS Australia and Australian MS researchers play an integral role in In 2016, MS Research Australia undertook a large-scale survey of people affected by MS
the global efforts to solve MS. in Australia to ascertain their research priorities. Well over 1000 people responded to the
MS Research Australia and MS Australia are active participants of the international survey. This large sample size was endorsed as being highly representative of the Australian
federated body called the Multiple Sclerosis International Federation (MSIF). Over 40 MS MS population by senior epidemiologists at the Menzies Institute for Medical Research.
organisations throughout the world are, or have been, involved with the global federation. It The survey results conclusively revealed that the top three research priorities for people
has given people affected by MS, MS societies, organisations and researchers from all over affected by MS in Australia are:
the world a chance to successfully collaborate together on items of global importance to
people with MS, including research, treatment access, support, services and quality of life.
MS Research Australia and Australian MS researchers have been involved in numerous
global initiatives that are making huge strides in improving our understanding of MS and the
treatment of MS. Examples of this include: 1 FINDING A CURE FOR MS
via repair and regeneration
• The International MS Genetics Consortium in which Australian MS researchers
2
played a pivotal role. BETTER
• MS Research Australia joined the world-first International Progressive MS Alliance TREATMENTS and
as a managing member – a global success story in accelerating treatments for MANAGEMENT
progressive forms of MS.
of MS
• Melbourne based team founded and managed the largest clinical MS database in
the world, called MSBase.
• A wealth of individual collaborations between Australian MS researchers and their
global counterparts.
3
• MSIF global research team collaborations including the International Patient PREVENTION
Reported Outcomes (PROs) initiative seeking to harmonise and collaborate on the of MS
collection and use of PROs for research, clinical trials, drug approvals and clinical
management of MS.
Fundraising for MS research
National or global research programs can only function with adequate funding. In 2012, These priorities are the same regardless of where along the journey of MS people are:
MS Research Australia launched its fundraising platform called Kiss Goodbye to MS. The whether they are newly diagnosed or have lived with the condition for years, or whether they
campaign has now become the signature fundraising initiative for the global federation and are mildly or severely affected by MS.
has been rolled out in over 13 countries throughout the world. The Kiss Goodbye to MS
campaign has a large social media footprint throughout the world and has proved to have
significant traction with younger people affected by the disease no matter where in the
world they live.
12 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 13
OBJECTIVE 1
Better treatments, prevention and,
ultimately, a cure for the disease
Priority 1 – Build Research Capability
and Capacity
There are three overarching priorities that will deliver the research outcomes for people with Introduction
MS in Australia. Each of these priorities are interlinked to the overall Roadmap to Defeat MS Invest in and expand promising signature areas of best quality, competitive and impactful
in Australia. research for MS through targeted research grants and capacity building through innovative
The priorities are: fellowship schemes.
1. Build research capability and capacity: through fellowships and clinician-researcher Destination
grants;
Capacity and capability is expanded and coordinated in signature areas of research with
2. Harness and improve collaborative research efforts through infrastructure: a significant progress towards a cure via the repair and regeneration of cells.
nationally funded infrastructure for deeply characterised patient cohorts, interlinking
clinical and patient reported data and biobanks, available to all researchers; and Aims
3. Clinical trials and clinical trial enabling infrastructure: to accelerate new treatments There are two key aims (please see details in table below):
and ultimately find a cure for and prevention of MS.
• Stimulating the translation of strong Australian discovery research on myelin repair and
neuroprotection for MS into pre-clinical and clinical studies by developing a targeted
program for research into these agents;
• Building the workforce and capabilities needed to achieve this, including developing
strong connections between laboratory and clinical research, industry and other
stakeholders through expansion of fellowship, paired fellowship and incubator programs.
1.1 $20m for innovative pre-clinical and clinical research studies on nerve
repair and protection to minimise the impact of all forms of MS.
ACTIVITY DETAIL
New and innovative pre-clinical and clinical Establish a fund for a targeted call for
studies on myelin repair and nerve protection applications for innovative pre-clinical
for MS. and clinical studies of novel myelin repair
and neuroprotection interventions and the
biomarkers and assays required to monitor
drug efficacy in trials. The grant program
will fund a portfolio of projects with clinical
and commercial potential and bring them
to proof-of-concept stage ready for further
commercial investment.
Further research and development of the Establish a fund to provide follow-on funding
most promising preclinical and clinical to support further research and development
outcomes from the above activity. of the most promising outcomes of the
above projects.
Dr Kaylene Young
14 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 15
Priority 2 – Harness and Improve
1.2 $12m investment over ten years in competitive and prestigious
researcher programs to retain, sustain and grow the pool of high
quality researchers in Australia; individuals who have excelled or Collaboration through
Shared Infrastructure
show potential to excel in MS research.
ACTIVITY DETAIL
Expansion of the successful competitive Establish a fund to continue to support new Introduction
paired fellowship program (clinician and competitive paired fellowships. MS Research Collaboration in the MS research space in Australia is incredibly well established and
researcher working together as a pair), Australia’s unique Paired Fellowship program effective. With further integrated funding and coordination, MS Research Australia is
dedicated to translational research to better was established in 2017 to facilitate cutting- well positioned to capitalise on this and support our Australian experts to drive home the
treat, prevent and find a cure for MS. edge clinical research by funding a Senior
progress and momentum that has been achieved to date and make a lasting difference for
Research Fellow and dedicated research
people living with MS.
time for a Clinical Practitioner Fellow to
collaborate on a shared program of research Enormous strides in understanding the risk factors for MS, developing treatments and
that will accelerate translation of research measuring disease outcomes have been made. It is in these areas that increased investment
outcomes into clinical practice. in shared infrastructure and further collaboration will be most valuable. With a concerted
effort we can use these advancements to ensure that the management of MS is targeted,
Investment in longer-term competitive and Expand MS Research Australia’s signature optimised and personalised – the right treatment, for the right person, at the right time – and
prestigious senior research fellowships and senior research fellowship (for laboratory that we translate our knowledge into the causes of MS to prevent MS and the consequences
senior clinical practitioner fellowships to researchers and clinicians) program to
of MS (primary and secondary prevention).
allow their promising research programs the enable them to focus on long-term research
time to come to fruition. programs. The 2016 Focussed Workshop of the European Committee for Treatment and Research in
MS (ECTRIMS)2 concluded that:
Expansion of the existing one-year incubator Expansion of the incredibly successful MS
• 60% of MS cases could be prevented if smoking, vitamin D, obesity and glandular fever
grants designed to stimulate innovative Research Australia Incubator grant program
were addressed;
research. to fund a larger number of small pilot grants
of $25,000 each which allow researchers • 9 0% of MS could be prevented if an Epstein Barr Virus (EBV) vaccine was also developed.
to get innovative new ‘out of the box’ ideas
and discoveries off the ground. These grants Destination
on average leverage 27 times the original
Research collaboration and infrastructure are boosted to improve diagnosis, prognosis and
investment through follow on grants.
treatment selection for a personalised approach to the management of MS and ultimately
up to 90% of new cases of MS are prevented.
Aims
There are two key aims (please see details in the table overleaf):
• Develop national data and registry infrastructure, including cross-disease approaches,
to coordinate the collection and analysis of data on individual diagnostic, prognostic,
and preventative factors to personalise treatment and target prevention of MS.
• Collaborate nationally and internationally to develop and test strategies to minimise the
impact and prevent the consequences of a diagnosis of MS.
16 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 172.1 $5.5m to develop and improve infrastructure aimed at optimising
personalised management and prevention of MS. 2.2 $3m to improve the secondary prevention of MS by addressing
modifiable lifestyle risk factors.
ACTIVITY DETAIL ACTIVITY DETAIL
Identify at-risk individuals and identify Both primary and secondary prevention Address smoking, obesity, physical activity Establish and support the development
diagnostic, prognostic and treatment strategies will be most successful if combined for the primary prevention of MS. and integration of communications and
response biomarkers through the with methods to definitively identify the most behaviour change support targeted at high
establishment of a national registry and data at-risk individuals. Develop and coordinate risk populations and monitor ongoing MS
research platform. a national collaborative research platform diagnoses in the target population via the
to utilise existing and emerging evidence registry infrastructure.
to develop integrated genetic, clinical,
Partner with public health initiatives to
imaging and fluid biomarker signatures
develop, trial and evaluate effective behaviour
and algorithms to enable screening and
change interventions for smoking prevention
stratification of populations with, and at risk
and cessation and obesity prevention in high
of MS to feed into trial designs and treatment
risk populations and monitor outcomes via a
strategies.
targeted registry.
Enabling platforms for clinical trials. Develop a shared national coordination and
Target secondary prevention of MS Work nationally and internationally to develop
infrastructure platform for MS clinical trials
via the adoption of a brain healthy lifestyle and implement a strategy targeting adoption
in Australia to maximise access, efficiency,
for people with the earliest signs of MS. of recommendations on modifiable lifestyle
comparability and data use from clinical trials
factors, with a focus on smoking, diet,
for MS – to be integrated with the shared
physical activity, obesity and other identified
data and registry infrastructure in the above
risk factors including co-morbidities,
activity and articulated with international MS
associated with worse outcomes in MS.
clinical trials platforms and consortia.
Ongoing research to develop and test robust
Develop international collaborative links to Work nationally and internationally to drive and pragmatic lifestyle interventions for
address glandular fever and an EBV vaccine. a focussed international effort to develop optimal brain health in people with MS and
and test an EBV vaccine. This is likely to those at high risk of MS.
include identifying the most promising
vaccine candidate(s), developing a feasible
multinational trial design to evaluate efficacy
for MS prevention and identifying funding
sources to conduct the necessary large,
population-based MS prevention study.
Expansion of the Australian Immunological Support the ongoing work of the Australian
Alliance model to collaborate on common Immunological Alliance with support costs
areas of research to identify triggers and and a common fund to ensure momentum
prevention strategies for autoimmune, and progress on common research priorities.
immunological and neurological diseases.
Develop a similar approach on common
research priorities with other neurological
diseases.
18 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 19Priority 3 – C
linical Trials to cure and 3.1 $8m to support national clinical trials and Australian arms of
international clinical trials.
prevent MS ACTIVITY DETAIL
Introduction Grant program for innovative clinical trials Establish a competitive fund for collaborative
for progressive and/or relapsing MS relating investigator-led, clinical trials for relapsing and
While a range of medications are available for people with relapsing forms of MS and to promising drug targets or interventions. progressive MS including both national trials
one single medication has recently been approved by the Australian Therapeutic Goods and Australian arms of international trials.
Administration (TGA) for primary progressive MS, these medications are not effective for all Consideration will be given to pharmaceutical
people with MS and can come with a host of risks and side effects. There remains an urgent and non-pharmaceutical interventions,
need to increase treatment options for people with MS, especially for progressive MS. Work and should include the development and
is underway worldwide to address this and there is gathering national and international validation of assays, biomarkers and tools
momentum towards clinical trials in a number of innovative areas for MS. for monitoring treatment outcomes in clinical
trials, stratifying patients and optimising a
Funding is needed to ensure that Australians living with MS can fully participate and gain personalised approach to treatment.
access to these clinical trials. In particular, there is intense activity in the development and
testing of repurposed medications and other interventions with low commercial interest Expand Australian research-driven, clinical Establish a competitive fund to support
but potentially high impact for people living with MS. Not least, the significant momentum trial activity relating to innovative cell and Australian clinical research centres to
being driven by the International Progressive MS Alliance, of which MS Research Australia gene-based therapies for MS. participate in international collaborations for
is a managing member will soon see numerous progressive MS clinical trials coming down the development and trialling of innovative,
the pipeline. This includes a range of emerging cell and gene based therapies for MS. emerging cell- and gene-based therapies for
Concerted funding is needed to support innovative clinical trials in Australia and Australian MS, with initial priorities to include AHSCT,
participation in international trials of these up and coming agents for the treatment of MS. mesenchymal stem cells, and cell-based
therapies targeting established risk factors
Clinical trials are also the only way to answer the question of whether MS can be prevented in and disease mechanisms in progressive MS.
those at risk. Australian research in this area is strong and it is paramount that we complete
ongoing clinical trials on whether vitamin D or UV could be used to prevent conversion
3.2
to MS. Analysis of these trials alongside other international evidence will underpin the
development of guidelines for clinical practice for at risk populations. $2.5m to support and implement clinical studies that aim to prevent MS.
In addition, support for infrastructure and collaboration is needed to enhance access to
ACTIVITY DETAIL
Autologous Haematopoietic Stem Cell Transplant (AHSCT) as a treatment for MS. This
therapy is currently offered at two centres in Australia as part of clinical observational trials Address low vitamin D and UV. Complete the ongoing Australian clinical
and access needs to be greatly improved for those for whom it is appropriate. trial into the prevention of MS using vitamin
D (PrevANZ) and analyse results in concert
Destination with international vitamin D trials and the
Australian PhoCIS UV trial.
Australia plays a leading role in clinical trials for MS treatments and Australian participation
in international trials is enhanced, leading to earlier access to treatments for Australians with Develop guidelines on appropriate vitamin
D supplementation and safe UVB exposure
MS. Clinical trial activity determines the role for environmental factors in the prevention of MS.
for the general population and at risk
populations. Conduct registry-based
Aims evaluation of implementation and efficacy
There are three key aims (please see details in the table opposite): of these guidelines.
Support international working group to
•
Supporting innovative clinical trials for promising drug targets for relapsing and
explore primary prevention trials for MS.
progressive MS.
• Expand clinical trials and access to cell based and gene based therapies for MS.
• Enhance access to AHSCT through the development of centres of excellence.
20 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 213.3 $2m to expand access to Autologous Haematopoietic Stem Cell
Transplant (AHSCT) for MS.
ACTIVITY DETAIL
Expanding access, via research-driven Establish and support a research platform
centres of excellence, to AHSCT for people and network for AHSCT for MS. The
living with MS where this is deemed the platform will include support for a national
optimal approach. network of centres of excellence providing
AHSCT for MS in Australia. The network
will be supported with ongoing registry
infrastructure to facilitate data-gathering
and research.
Explore collaboration with and support
for international trials to expand access to
treatment trials of AHSCT for people with MS
in Australia and contribute to the international
data-gathering on this treatment modality.
Professor Gilles Guillemin and
Dr Edwin Lim
22 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 23OBJECTIVE 2
Improved Management and Care of
People living with MS
MSSNs provide holistic and specialist support in symptom management and are the key
support that assists the patient and their family to navigate a complex number of service
systems (health, disability, community and aged care), to access the right support at the
right time. They work closely with medical staff in providing practical and individualised
information for patients to make informed choices on treatment options best suited to their
Introduction MS and lifestyle. They also assist with safety and monitoring reporting which is crucial
Ensure all people with MS have access to the best possible models of care from onset to avoid serious adverse reactions especially in respect to several of the newer disease
of symptoms, through diagnosis and ongoing treatment and management, including modifying therapies.
monitoring of treatment efficacy.
Research nationally and internationally has highlighted the economic argument for
Improving the management of people affected by MS will be achieved by the outcomes of employing specialised nurses in the management of chronic diseases3.
some of the activities in Priority 1 & 2. This will be further enhanced by investment in the
Research articles that demonstrate a clear economic argument to employ MSSN include
health care team that supports people living with MS (Priorities 3 & 4) to optimise treatment,
the 2015 ten year retrospective evaluation study conducted in the UK, which found that the
minimise disease and disability progression and assist in maintaining quality of life including
introduction of a proactive nurse-led management and rapid response service of MSSNs
employment.
in one health area - including the implementation of a care pathway in the emergency
$2 million will be used to establish, build and audit vital national care pathways, including department for patients who present with MS - was associated with a reduction from a
the development of the health care team integral to these care pathways. mean of 2700 bed-days per year to a mean of 198 bed days per year 4.
Foundational to an optimal MS health care team is the specialist MS Nurse. Additionally, there is clear evidence of patient preference for the use and perceived value
Multiple Sclerosis Specialist Nurses (MSSNs) are an established and essential part of the of MSSNs5.
multidisciplinary team of specialist health professionals supporting people with MS. They
play a key role in information, advice and support for patients, family and carers, at the Destination
point of diagnosis and ongoing. Access to early interventions and the most effective treatment therapy is well established.
• Optimal models of MS care pathways are well established.
• The time taken from onset of symptoms to diagnosis, treatment and adoption of a brain-
healthy lifestyle is significantly reduced.
MS NURSE
• Evidence-based lifestyle interventions are well understood by clinicians and adopted by
people living with MS.
• Number of MS Nurses in Australia is dramatically increased.
Aims
There are four key aims that encompass this objective:
• Recognising the critical importance of early diagnosis, early treatment and appropriate
monitoring.
• $ 2m investment to establish, build and audit national care pathways.
• Empower patients and clinicians with evidence based information on the role of lifestyle
factors for a holistic approach to managing MS.
ADVICE AND ACCESS HOLISTIC AND MONITORING OF • Expand the number of specialist MS nurses in Australia to support effective disease and
TO CORRECT SERVICES SPECIALIST SUPPORT TREATMENT OPTIONS symptom management in the primary care setting.
24 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 251 Recognising the critical importance of early diagnosis, early treatment
and appropriate monitoring. 2 $2m investment to establish, build and audit national care pathways.
ACTIVITY DETAIL ACTIVITY DETAIL
1.1 Increase understanding of MS within Work with the Primary Health Networks, 2.1 Establish, build and audit national care Fund a dedicated project manager to
primary health and across the wider Health Pathways team, GPs and other pathways to support decision-making work with the Primary Health Network,
community to expedite diagnosis and health care peak organisations to increase by healthcare professionals and their Health Pathways team to implement
referral to an expert in MS, as per the awareness of MS symptoms and the patients. the recommendations of the Brain
recommendations of the international benefits of early diagnosis, treatment and health: time matters in multiple sclerosis
consensus initiative, Brain Health: adoption of a brain-healthy lifestyle. This international consensus standards for
Time Matters in MS. will include developing and promulgating the management of MS with a focus on
evidence-based ‘best practice’ care diagnosis, treatment and lifestyle change.
pathways and disseminating material Work with Primary Health Networks,
such as the “Brain Health: time matters MS Nurses Australasia, ANZAN MS
in multiple sclerosis” guide as widely Neurologists, patients and MS clinics
as possible. to evaluate, audit and adjust pathways
Continue broad-based advocacy and of care to achieve the internationally
communications work to improve established standards of best practice in
understanding of MS in the broader MS diagnosis and management.
Australian community, with a particular
emphasis on the importance of 2.2 Increase access to diagnostic tools Partner with other peak organisations
recognising symptoms early, expediting including blood tests and magnetic to advocate and lobby for increased
diagnosis and treatment and adopting a resonance imaging (MRI). affordable access to diagnostic tools
brain-healthy lifestyle. such as blood tests and MRIs by building
on recent commitments to increase
the number of MRI machines across
Australia,
Urgently address the cost of these tests
for patients, to ensure cost is not a
barrier to obtaining a diagnosis and close
monitoring of treatment response and
disease progress.
2.3 Enhancement of widely-accepted and Building on the work detailed in 1.1 on
best practice prescription of currently the opposite page, work with the Primary
available MS medications to enable Health Networks, GP and other health
the individuality of the disease to care peak organisations to increase
be matched by tailored and optimal awareness by both health care providers
treatment. and people newly diagnosed with MS,
of the various MS treatment options
available.
26 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 273 mpower patients and clinicians with evidence based information on the
E
role of lifestyle factors for a holistic approach to managing MS. 4 Expand the number of specialist MS nurses in Australia to support effective
disease and symptom management in the primary care setting.
ACTIVITY DETAIL ACTIVITY DETAIL
3.1 Provide patients and clinicians with Building on the outcomes and resources 4.1 Implement a range of contemporary Collate evidence as to the efficacy of
evidence based information on the role developed as part of Objective 1, we mechanisms, including telehealth, to a range of contemporary mechanisms
of lifestyle factors in MS. will utilise a range of on-line and social enable MS specialist nurses (MSSNs), in improving access and specialised
media channels to provide healthcare to provide specialised support and support for people living with MS in rural
professionals with contemporary, care to people with MS in rural and and remote Australia.
evidence based information on the role of remote locations, either directly or via
It is anticipated that the intervention of a
lifestyle factors on brain health to assist local health professionals to assist
MSSN will improve MS patient outcomes
in adoption at the point of diagnosis. in coordinating a multidisciplinary
such as quality of life, employment
care approach to achieve optimal MS
stability, delay in progress of disability,
3.2 Continue to develop the evidence in Partnering with existing public health patient outcomes.
plus reduced requirement for high
this area and minimise the impact and programs to promulgate evidence needs care.
progression of the disease. for the impact of lifestyle factors on
the management of MS to increase
4.2 Implement a project to provide Establish an advisory group of key health
adherence and long term gains, with
evidence of the impact of specialist professionals and peak bodies to design
consideration for the unique challenges
nurse support in neurologist-led a project to support the implementation
for people living with MS (including the
MS clinics. of this specialist role.
specific barriers of physical, cognitive,
mental health and fatigue symptoms This project will utilise a clinic currently The MS specialist nurse will monitor and
that accompany a diagnosis of MS). without an MS nurse to establish proactively manage MS patients through
baseline data on key measures coordination of services, strengthening
including symptom management, referral pathways and assisting with
accide nt a nd e me rge ncy support for advanced therapies.
presentations, hospital stays and the
This project will gather data to build
prevention of disease progression,
on the evidence base described in the
prior to establishing an MS nurse in
introduction to this section of the Plan,
that setting and collecting evidence
and provide a value proposition, further
of the impact of the MS nurse role.
demonstrating the benefits of employing
specialist MS nurses.
4.3 Identify and establish data collection Work closely with MS Nurses Australia
systems to build an evidence base and other MS peak bodies to develop,
regarding the most effective nursing adopt and promulgate an Australian
interventions to improve symptom model of MS care, including best practice
management, provide effective guidelines and established standards for
multidisciplinary care, delay and treating, supporting and caring for people
minimise disease progression and with MS in Australia.
empower the person with MS to
maintain the best possible health
and wellbeing.
28 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 29Next Steps and Early Priorities Step 2: Implementation oversight group to take action
Immediate and early implementation of the Roadmap will include:
Once adequate funding has been secured to ensure the Roadmap to Defeat MS fulfils its
objectives, the following is suggested: • Calling for a series of competitive Requests for Funding Applications (RFAs) via the
robust, current and impactful mechanisms of MS Research Australia, specifically
Step 1: Establish an Implementation Oversight Group targeting the key identified MS research priorities areas (gaps and opportunities),
• Establish an Implementation Oversight Group to facilitate and monitor the implementation these are:
of the Roadmap. This group will consist of the following members: -- Advancing Australian strengths in myelin repair and neuro-protection research.
-- Representative from MS Research Australia Board -- Better understanding the underpinning cellular mechanisms of MS progression.
-- Representative from MS Australia Board -- Enhancing translational Australian research designed to provide treatments and
-- MS Research Australia CEO or nominated representative interventions for people living with progressive MS.
-- MS Australia CEO or nominated representative -- Modifiable lifestyle factors in MS management, symptom management interventions
for fatigue, pain and cognition in MS.
-- MS Clinician
• Competitively enhancing the translational research and clinical trial capacity of current
-- MS Biomedical Researcher and potential therapies for MS including Autologous Haematopoietic Stem Cell
-- MS Social and Applied Researcher or Allied Health Professional Treatment (AHSCT) and other cell based therapies aimed at supporting and increasing
areas of existing clinical and research strengths in Australia.
-- Industry/Commercialisation Expert
•
Establishing a competitive and robust research translational grants program to
-- Consumer advocate (2 people) specifically support investigator-led pre-clinical (proof of concept) and clinical trials
MS Research Australia and MS Australia will manage implementation of the Roadmap with of novel MS therapies including re-purposing medications for myelin repair and
the Implementation Oversight group, supported and advised by subcommittees as required neuroprotection.
for individual initiatives. • A collaboration between MS Australia and MS Research Australia on advocacy and
awareness using evidence-based interventions to change public policy leading to
earlier intervention, and prevention of the development and progression of the disease.
• Establishing a model high quality care pathways for MS and working with the Primary
Health Networks across Australia in their local implementation.
• Implement a working party to progress development of research into the impact of
lifestyle changes on the progress of MS.
• Expand the current MS specialist nurse project to develop an evidence base for growth
of the MS nursing workforce.
• Establish best-practice monitoring, oversight and milestone developments.
30 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 31References
1. T
he Health Economic Impact of Multiple Sclerosis in Australia 2017 report, commissioned by
MS Research Australia and prepared by the Menzies Institute for Medical Research, University of Tasmania
https://msra.org.au/wp-content/uploads/2018/08/health-economic-impact-of-ms-in-australia-in-2017_ms-
research-australia_web.pdf
2. Amato MP, Derfuss T, Hemmer B, Liblau R, Montalban X, Soelberg Sørensen P, Miller DH; 2016 ECTRIMS Focused
Workshop Group. Environmental modifiable risk factors for multiple sclerosis: Report from the 2016 ECTRIMS
focused workshop. Mult Scler. 2017 Jan 6:1352458516686847. doi: 10.1177/1352458516686847.
3. Mynors G, Suppiah J, Bowen A 2015, Evidence for MS Specialist Services: Findings from
the GEMSS MS Specialist Nurse Evaluation Project, Multiple Sclerosis Trust, Hertfordshire.
https://support.mstrust.org.uk/file/Evidence-for-MS-Specialist-Services.pdf
4. L
eary A, Quinn D & Bowen A 2015, Impact of proactive case management by Multiple Sclerosis specialist nurses
on use of unscheduled care and emergency presentation in Multiple Sclerosis - a case study. International Journals
of MS Care, Volume 17(4), pp. 159-163.
5. H
olliday C, Hafiz N, Barclay C & Dangol P 2016, Multiple Sclerosis Program of Work: Multiple Sclerosis Study &
Multiple Sclerosis Community Forum, s.l.: Genzyme, MS Australia. Centre for Community-Driven Research.
6. G
iovannoni G, Butzkueven H, Dhib-Jalbut S, Hobart J, Kobelt G, Pepper G, Sormani MP, Thalheim C, Traboulsee A,
Vollmer T., Brain Health: time matters in multiple sclerosis report www.msbrainhealth.org/report
Acknowledgements
Many individuals have contributed to the development of this Implemention Plan for
A Roadmap to Defeat Multiple Sclerosis in Australia, we would like to especially thank
the following:
Project team Contributors
Dr Matthew Miles, CEO, The Hon. Greg Hunt
MS Research Australia Office of the Minister for Health
Dr Lisa Melton, Head of Research, The Hon. Catherine King
MS Research Australia
Simon McKeon AO
Dr Julia Morahan, Deputy Head of Research,
MS Research Australia Jillian Kingsford Smith
Petricia Augustus, Head of Lauren Butterly
Communications, Marketing and Operations,
MS Research Australia
Lizzy Morton, Marketing and
Communications Coordinator,
MS Research Australia
Deidre McKechnie, CEO,
MS Australia
Therese Burke, Andrew Giles, National Policy Officer,
MS Nurse MS Australia
32 Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia Implementation Plan for A Roadmap to Defeat Multiple Sclerosis in Australia 33For more information about multiple sclerosis in general and the work of MS Australia, please contact: 1300 010 158 or visit www.msaustralia.org.au For more information about research into multiple sclerosis and the work of MS Research Australia, please contact: 1300 356 467 or visit www.msra.org.au
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